Thoraflex Hybrid Post-Market Study (THOR)

• ClinicalTrials.gov Identifier: NCT03414866
• Recruitment Status: Active, not recruiting
• First Posted: January 30, 2018
• Last Update Posted: September 16, 2021
• Sponsor: Vascutek Ltd.
• Information provided by (Responsible Party): Vascutek Ltd.

Study Description

Brief Summary:

This is a global, prospective non-interventional, multi-centre, post-market study of the Vascutek Thoraflex™ Hybrid system in patients with acute thoracic aortic syndrome, subacute/chronic dissection of the aorta and aortic aneurysm.

Condition or disease	Intervention/treatment
Acute Aortic Dissection; Aortic Rupture; Penetrating Aortic Ulcer; Aortic Dissection; Aortic Aneurysm, Thoracic	Behavioral: EQ-5D-5L QOL questionnaire

Detailed Description:

Aortic arch pathologies are rare, but pose significant challenges for treatment involving open surgical or endovascular repair.

In 1983 the Elephant Trunk technique was introduced and has greatly facilitated the management of patients with extensive thoracic aortic disease.

In recent years, this traditional open surgery has been combined with thoracic endovascular repair (TEVAR) and this is known as the 'hybrid' approach. Hybrid repairs, consisting of an open surgical repair combined with endovascular techniques.

Further advancement in the types of prosthesis available has resulted in the evolution of the conventional ET technique into the frozen elephant trunk (FET) technique. This utilises devices that incorporate both a traditional dacron graft (for open surgical treatment of the aortic arch) and a stented graft portion (for treatment of the descending thoracic aorta). The stented portion of the graft is introduced via an antegrade approach through the transected arch. The FET technique is now commonly used to treat patients with extensive thoracic or thoraco-abdominal aortic disease.

Vascutek Ltd has developed the Thoraflex™ Hybrid Device (Plexus™ 4 and Ante-Flo™) for the repair or replacement of damaged or diseased vessels of the ascending aorta, aortic arch and descending thoracic aorta in cases of aneurysm and/or dissection. The Thoraflex™ Hybrid Device is one of the commercially available frozen elephant trunk prosthesis.

Over 3000 Thoraflex™ Hybrid Devices have been sold and the current study seeks to provide further evidence of the continuing safety and effectiveness of the device.

Study Design

• Study Type: Observational
• Actual Enrollment: 182 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Thoraflex Hybrid Post-Market Study
• Actual Study Start Date: May 25, 2018
• Estimated Primary Completion Date: February 25, 2025
• Estimated Study Completion Date: July 2026

Groups and Cohorts

Group/Cohort	Intervention/treatment
Acute thoracic aortic syndrome; 60 patients, standard of care (non-interventional) EQ-5D-5L QOL Questionnaire	Behavioral: EQ-5D-5L QOL questionnaire; Written questionnaire
Subacute/chronic dissection of the aorta; 60 patients, standard of care (non-interventional) EQ-5D-5L QOL Questionnaire	Behavioral: EQ-5D-5L QOL questionnaire; Written questionnaire
Aortic aneurysm; 60 patients, standard of care (non-interventional) EQ-5D-5L QOL Questionnaire	Behavioral: EQ-5D-5L QOL questionnaire; Written questionnaire

Outcome Measures

Primary Outcome Measures :

1. Freedom from Major Adverse Event [ Time Frame: 1 year post-procedure ]
   The primary endpoint will be freedom from the following composite Major Adverse Event (MAE): permanent stroke , permanent paraplegia/paraparesis, unanticipated aortic related re-operation (excluding re-operation for bleeding) and aortic related mortality

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

60 patients with acute thoracic aortic syndrome, including: acute dissection, aortic rupture and penetrating aortic ulcer (PAU)

60 patients with a subacute/chronic dissection of the aorta

60 patients with an aortic aneurysm

Criteria

Inclusion Criteria:

• Patient is aged 18 years or over on date of consent
• Patient is willing and able to comply with all study procedures and study visits
• Patient or their legally authorised representative (LAR) has given written informed consent to participate in study. For emergency patients only, retrospective consent is permissible
• Patient satisfies the inclusion criteria for one of the following categories:

A - Patient has acute thoracic aortic syndrome or B - Patient has subacute/ chronic dissection of the aorta or C - Patient has an aortic aneurysm (including connective tissue disorders)

A. Patients with acute thoracic aortic syndrome:

Patient has acute thoracic aortic syndrome and requires repair or replacement of damaged or diseased vessels of the aortic arch (with or without involvement of the ascending aorta), and the descending aorta requires replacement, or, in the opinion of the investigator, the patient would derive clinical benefit from prophylactic treatment of the descending aorta. This includes patients with acute dissections, rupture of the aorta or PAU.

B. Patients with subacute/chronic dissection of the aorta:

• Patient requires repair or replacement of damaged or diseased vessels of the aortic arch and descending aorta with or without involvement of the ascending aorta due to subacute/chronic dissection.

And patient satisfies one or more of the following criteria:

• Patient has aortic sinus, or ascending aorta, or aortic arch, or descending aorta diameter ≥5.5cm (including if asymptomatic) or
• Patient has aorta diameter <5.5cm and growth rate ≥0.5cm/year (including if asymptomatic) or
• Patient has ascending aorta diameter ≥4.5cm and requires valve repair or replacement

C. Patients with an aortic aneurysm (including connective tissue disorders):

• Patient requires repair or replacement of damaged or diseased vessels of the aortic arch and descending aorta with or without involvement of the ascending aorta

And patient satisfies one or more of the following criteria:

• Patient has aortic sinus, or ascending aorta, or aortic arch, or descending aorta diameter ≥5.5cm (including if asymptomatic) or
• Patient has aorta diameter <5.5cm and growth rate ≥0.5cm/year (including if asymptomatic) or
• Patient has ascending aorta diameter ≥4.5cm and requires valve repair or replacement.

or

• Patient has Marfan syndrome or other genetically mediated disorders with aortic sinus, or ascending aorta, or arch diameter ≥4.5cm, or, the ratio of the maximal ascending or aortic root area (Π r2) in cm2 divided by the patient's height in meters exceeds 10

Exclusion Criteria:

• Patient is unfit for open surgical repair involving circulatory arrest
• Patient has known sensitivity to polyester, nitinol or materials of bovine origin
• Patient has active endocarditis or an active infective disorder of the aorta
• Patient has an active systemic infection that, in the opinion of the investigator, would compromise the outcome of the surgical procedure
• Patient is enrolled in another active study and has received an investigational product (device, pharmaceutical or biologic) within 6 months prior to the date of the implant or has not reached the primary endpoint of the study, which in the opinion of the Investigator will impact on this study
• Patient has an uncorrectable bleeding anomaly
• Patient has renal failure (defined as dialysis dependent)
• Patient has known sensitivity to radiopaque contrast agents that cannot be adequately pre-treated
• Patient has a co-morbidity causing expected survival to be less than 1 year
• Patient has any other medical, social or psychological problems that in the opinion of the investigator preclude them from receiving this treatment and the procedures and evaluations pre and post procedure

Contacts and Locations

Locations

Canada, Ontario

London Health Sciences Centre, University Hospital

London, Ontario, Canada, N6A 5A5

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

Toronto General Hospital

Toronto, Ontario, Canada

Germany

University of Freiburg

Freiburg, Germany

Hannover Medical School

Hanover, Germany, 30625

Italy

Policlinico S.Orsola-Malpighi

Bologna, Italy

Netherlands

St Antonious Hospital

Nieuwegein, Netherlands

Sponsors and Collaborators

Vascutek Ltd.

Investigators

• Principal Investigator: Malakh Shrestha, Prof. Dr.; Hannover Medical School

More Information

• Responsible Party: Vascutek Ltd.
• ClinicalTrials.gov Identifier: NCT03414866
• Other Study ID Numbers: THOR-001
• First Posted: January 30, 2018
• Last Update Posted: September 16, 2021
• Last Verified: September 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Vascutek Ltd.:

Thoracic Aorta; Dissection; Aneurysm; Frozen Elephant Trunk

Additional relevant MeSH terms:

Aneurysm; Aortic Aneurysm; Aneurysm, Dissecting; Aortic Aneurysm, Thoracic; Aortic Rupture; Rupture; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Wounds and Injuries; Aneurysm, Ruptured